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FDA 510(k)

ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6

K-Number: K092997 · 2009-11-10

ApplicantEdan Instruments, Inc.
Decision Date2009-11-10
Product CodeKNG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2009-11-10 under 510(k) number K092997. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6?

ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 is a medical device that received FDA 510(k) clearance on 2009-11-10. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K092997.

When did ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 receive FDA 510(k) clearance?

ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 received FDA 510(k) clearance on 2009-11-10, under 510(k) number K092997.

Who is the listed applicant for ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6?

The FDA 510(k) record lists Edan Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6?

The FDA product code for ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 is KNG.

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Related Devices (Code: KNG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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